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Internet-based intervention to support smoking cessation for Chinese smokers


- candidate number24487
- NTR NumberNTR5898
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jun-2016
- Secondary IDs2016-DP-7125 
- Public TitleInternet-based intervention to support smoking cessation for Chinese smokers
- Scientific TitleTrain to Quit: action tendency training and selective inhibition training over the internet in Chinese smokers
- ACRONYMTTQ
- hypothesisThe aim of the current study is to investigate the effectiveness of two online trainings: action tendency training and selective inhibition training on increasing smoking cessation among Chinese smokes.

Hypotheses:

1: It is expected that, for each of the training, participants in the active training conditions will show greater quitting rates, and/or less cigarette consumption per day, and/or craving, and/or nicotine dependence than participants in the placebo conditions.

We will also explore the training effects on two other variables, including explicit attitude about smoking, and self-efficacy to quit .

2: It is expected that, joint exposure to both active trainings condition will have a greater quitting rates, and/or less cigarette consumption per day, and/or craving, and/or nicotine dependence than each of the active trainings separately.

3: Action tendency training is hypothesized to decrease or reverse smoking-related approach bias, whereas there will be no change in bias in the placebo conditions.

4: Selective inhibition training is hypothesized to decrease or reverse smoking-related positive implicit associations, whereas there will be no change in associations in the placebo conditions.

5: It is expected that, the changed smoking-related approach bias will mediate the action tendency training effects on the quitting rates, and/or cigarette consumption per day, and/or craving, and/or nicotine dependence; and the changed smoking-related positive implicit associations will mediate the selective inhibition training effects on quitting rates, and/or cigarette consumption per day, and/or craving, and/or nicotine dependence.

We will also explore the generalization effect of action tendency training and inhibition control training on smoking-related approach implicit associations, respectively. And, we will also explore if this changed associations will mediate the training effects on the quitting rates, and/or cigarette consumption per day, and/or craving, and/or nicotine dependence.

6: There are three possible moderators will moderate the action tendency training effects on the quitting rates, and/or cigarette consumption per day, and/or craving, and/or nicotine dependence, and/or smoking-related approach bias:
smoking-related approach bias assessed at pre-test,
participants are heavy smokers or light smokers,
participants are successfully trained or not.
It is expected that participants with stronger smoking-related approach bias, or are heavy smokers, or are successfully trained will show greater quitting rates, and/or less cigarette consumption per day, and/or less craving, and/or less nicotine dependence, and/or less smoking-related approach bias from the action tendency training than participants with weaker smoking-related approach bias, or are lighter smokers, or are not successfully trained.

7: There are also three possible moderators will moderate the selective inhibition training effects on the quitting rates, and/or cigarette consumption per day, and/or craving, and/or nicotine dependence, and/or smoking-related positive implicit associations:
smoking-related positive implicit associations assessed at pre-test,
participants are heavy smokers or light smokers,
participants are successfully trained or not.
It is expected that participants with stronger smoking-related smoking-related positive implicit associations, or are heavy smokers, or are successfully trained will show greater quitting rates, and/or less cigarette consumption per day, and/or less craving, and/or less nicotine dependence, and or less smoking-related positive implicit associations from the selective inhibition training than participants with weaker smoking-related positive implicit associations, or are lighter smokers, or are not successfully trained.

We will also explore other three possible moderators: smoking-related approach implicit associations assessed at pre-test, impulsive personality assessed at pre-test, and self-control beliefs assessed at pre-test.
- Healt Condition(s) or Problem(s) studiedSmoking
- Inclusion criteriaParticipants are:

1. 18-65 years old
2. Chinese, understand Chinese well
3. smoked in a daily basis for at least one year
4. have motivation to quit smoking and would like to set a quitting day
5. can use computer, or smartphone, or tablet
6. can access to Internet daily at home or in workplace
7. no drug use
8. no mental disorders or dyslexia
- Exclusion criteriaParticipants are:

1. do not want to continue the study and tell us they want to quit from the study
2. do not want to quit smoking on the quitting day they choose at the second time (they will pick a quitting day when they registration. if they do not want to quit on that day, they will get the second opportunity to re-choose a new quitting day)
3. do not confirm their quitting attempts on the quitting day
4. do not want to finish half-way assessment during the study
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jul-2016
- planned closingdate15-jan-2017
- Target number of participants350
- Interventions1. Study design:

the study is a 2 2 randomized trial design, which results in 4 intervention conditions:
Condition 1: Active action tendency training + Active selective inhibition training
Condition 2: Placebo action tendency training + Active selective inhibition training
Condition 3: Active action tendency training + Placebo selective inhibition training
Condition 4: Placebo action tendency training + Placebo selective inhibition training

2. The trainings:

Participants will receive 9 sessions of either the active or the placebo version of the two trainings within about four weeks after their quitting day. The action tendency training aims at decreasing or reversing smoking-related approach bias; and selective inhibition training aims at decreasing or reversing smoking-related positive implicit associations. Participants are allowed to finish each training session within one week. But we recommend them to do the training 2-3 sessions a week. Every training session last about 30 - 40 minutes. After they finish each training, participants will get tailored feedback on their training performance.
- Primary outcomePrimary outcome names:
1. continuous abstinence (a self-report of smoking not more than 5 cigarettes from the start of the quitting day)
2. 7-day point abstinence (a self-report of not smoking at all during the one week before the assessment time points)
Time points: half-way of the treatment, after the treatment, 3-month follow-up, 6-month follow-up
- Secondary outcomeSecondary outcomes names:
1. changes in smoking-related approach bias
2. changes in smoking-related positive implicit associations
3. cigarette consumption per day
4. craving
5. nicotine dependence;
Time points: half-way of the treatment, and after the treatment

Other exploratory outcome names:
1. changes in smoking-related approach implicit associations
2. explicit attitude about smoking
3. self-efficacy to quit
Time points: half-way of the treatment, and after the treatment
- TimepointsGeneral speaking, there are four important time points to examine the training effects:
1. Half-way of the treatment (after 4th training session, about 4 weeks after pre-test)
2. after the treatment (after 8th training session, about 6 weeks after pre-test)
3. 3-month follow-up (about 4.5 months after the pre-test)
4. 6-month follow-up (about 7.5 months after the pre-test)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD candidate Si Wen
- CONTACT for SCIENTIFIC QUERIESProf. Reinout Wiers
- Sponsor/Initiator University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
Chinese grant from China Scholarship Council , University of Amsterdam
- PublicationsWe intend to publish in international peer-reviewed journals
- Brief summary
- Main changes (audit trail)
- RECORD15-jun-2016 - 8-jul-2016


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